CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 345 enrolled
Drug / intervention
Self-administered fluoridated dentifricesdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02647203
NCT02647203Phase 2Completed
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Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults

University of Talca·interventional·Posted Jan 6, 2016·Updated Jan 2, 2024

In Brief

A Phase 2 clinical trial evaluating Self-administered fluoridated dentifrices for Root Caries. Completed, enrolled 345 participants across 1 site.

Detailed Summary

This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day. Follow-up will be carries out every 6 months for two years to assess: * Root caries incidence. * Lesion arresting * Changes in salivary flow * Microbiology pattern shift * Variations in oral health- related quality of life by OHIP-14 Sp

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRoot Caries
CountriesChile
CollaboratorsFederal University of Rio Grande do Sul

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 6, 2016
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2016
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.5 years ago

Interventions

Self-administered fluoridated dentifricesdrug

Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.